510(k) K875283 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
QM2/QM300 CONTROL B PACK
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Feb 10, 1988 |
| Received | Dec 24, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K875283
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.